MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, best estimate (b)(6) 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a z9002 14.0 diopter intraocular lens (iol) was explanted due to residual refractive error.There was no patient injury and the patient has recovered.The lens was replaced with the same model, a larger 19.5 diopter lens.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 12/12/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturer.Visual inspection at 10x microscope magnification shows lens returned is cut in two pieces.Loose fibers/particles were observed on lens pieces related to the handling of the unit out of a sterile environment.Residue of lubricant material were also observed on lens pieces.Both haptics were observed slightly distorted.The conditions of the lens returned is consistent with a unit that has been previously handled and prepared for the surgical process.Due to the condition of the lens returned, the complaint issue reported could not be verified.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found the during process related to the complaint issue reported.There were no discrepancies found during the mrr (manufacturing record review).The units were manufactured and released according to the specifications.A search on complaints revealed no additional investigation request for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 7102199
• Report Number: 2648035-2017-02242
• Device Sequence Number: 16338742
• Product Code: HQL
• UDI-Device Identifier: 05050474530577
• UDI-Public: (01)05050474530577(17)211003
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 10/03/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention